Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a software defect that prevents proper filtering of antibiotic-susceptibility results. No illnesses or injuries have been reported, but the potential for incorrect antibiotic recommendations based on incomplete test data constitutes significant risk of harm, meeting the High (3) severity category.
Plain-English summary
Biomerieux Inc is recalling MYLA laboratory middleware that connects VITEK MS microbiology analyzers to hospital information systems. The software has a defect that prevents antibiotic-susceptibility test (AST) filter rules from being applied to test results before they reach clinicians.
Antibiotic-susceptibility testing identifies which antibiotics are effective against bacterial infections and helps prevent inappropriate antibiotic use. When filter rules are not applied, clinicians receive incomplete test data that could affect patient treatment decisions.
The recall affects 19 MYLA systems located in Alabama, California, North Carolina, and Puerto Rico. The defect impacts systems running MYLA versions 4.8.X and 4.9.
Laboratories using affected systems should contact Biomerieux Inc immediately to obtain necessary software updates ensuring that antibiotic-susceptibility filter rules are properly applied before results are reported to clinicians.
The recalled product
- Product
- MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
- Manufacturer
- Biomerieux Inc
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Versions 4.7 and 4.8
Distribution
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